CNS Indication definition

CNS Indication means any condition, disorder and/or disease primarily involving the central nervous system in humans or animals, and for which therapeutic treatment with a compound would require crossing of the blood-brain barrier by such compound.
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CNS Indication shall have the meaning set forth in Appendix A.
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CNS Indication means any disease, disorder or condition of the central nervous system in humans, including, without limitation, (i) [***] (i.e., [***], [***]), [***] (i.e., [***], [***], [***]), [***] (i.e., [***], [***]), [***] (i.e., [***]), and [***], [***], and (ii) [***], [***], [***], sporadic Alzheimer’s disease, familial Alzheimer’s disease, amyotrophic lateral sclerosis, Xxxxxxxxx’x disease, [***], [***], [***], [***], multiple sclerosis, Huntington’s disease, [***], Dravet syndrome and [***]. Notwithstanding the foregoing, CNS Indication shall not mean (a) any indication in which the treatment, prevention or amelioration of pain in any form would be a primary efficacy endpoint in a clinical trial or (b) any gastrointestinal disorder, non-central nervous system autoimmune disorder or cardiovascular disorder.
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Examples of CNS Indication in a sentence

  • At any time during the Term, each Party has the right to submit a development and commercialization proposal for the Compound in a potential new Orphan CNS Indication (other than the Initial Indications or any then-existing Additional Indications) for review by the JDC and approval or rejection by the CGB in accordance with Article 2.

  • The Joint Discovery Committee shall review select compounds that arise under the Beacon Agreement and are identified by Licensor as having potential utility for a CNS Indication, and decide whether to designate such compound for investigation by the Licensee (each such designated compound, an “ROFN Compound”).

  • In the case of a new Orphan CNS Indication recommended by the JDC, such meeting shall be held [*] following recommendation to the CGB, or as soon as reasonably possible.

  • If approved by the CGB, such new Orphan CNS Indication shall be an “Additional Indication”.

  • TG shall provide Company with written notice (a “New CNS Indication Notice”) of such New CNS Indication for the Product and a brief description of the associated Development activities (the “New CNS Indication Development Activities”) as well as a break-down, in reasonable detail, of the costs actually incurred and likely to be incurred in the future by or on behalf of TG following ​ ​ the Effective Date in connection with the performance of the applicable New CNS Indication Development Activities.


More Definitions of CNS Indication

CNS Indication means Schizophrenia and all other CNS diseases including, but not limited to, psychotic disorders, depression, anxiety, sleep disorders, pain, dementia, Alzheimer disease, cognitive disorders and attention disorders (ADHD).
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CNS Indication means degenerative diseases of the brain and central nervous system, including Alzheimer’s Disease, but excluding oncology indications.
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CNS Indication means any disease, disorder, or condition primarily affecting or manifesting in the brain, spinal cord, or peripheral nervous system (with the exception of and not including the enteric nervous system), including neurological, psychiatric, neuropsychiatric, pain, mental, and behavioral indications. Without limiting the foregoing, CNS Indications includes all indications within the ICD-10 code range of F01-F99 and G01-99. “CNS Symptoms” means a physiologically expressed symptom primarily manifesting in the brain, spinal cord or peripheral nervous system (with the exception of and not including the enteric nervous system) that is secondary to non-CNS Indications. CNS Indications shall include CNS Symptoms for the purposes of this Agreement. For clarity, indications that do not fall within the first sentence of this definition are not deemed to be CNS Indications by nature of the presence of CNS Symptoms. “Closing” means the closing of the transactions contemplated by this Agreement. “Combination Product” has the meaning set forth in the definition of “Net Sales”. “Code” means the Internal Revenue Code of 1986, as amended. “Confidential Information” means any and all Information that (a) is disclosed by one Party or its Affiliates to the other Party or its Affiliates under or in connection with this Agreement, whether in oral, written, graphic, or electronic form, and (b) concerns the Products, the Monash License (or the inventions disclosed or claimed therein), any Transferred Asset (including the Glyph Technology and the Monash License), which, in the case of the Confidential Information described in this subsection (b), will be deemed Seaport’s Confidential Information notwithstanding any prior access or knowledge by PureTech or any of its Controlled Affiliates, except that any such Confidential Information to the extent primarily relating to any Identified Product Concepts (and not any then-existing Products of Seaport) that is disclosed by PureTech to Seaport in furtherance of exercise of PureTech’s rights with respect to a PureTech License will be deemed PureTech’s Confidential Information notwithstanding any prior access or knowledge by Seaport or any of its Controlled Affiliates. “Contract” means any written or oral agreement, contract, subcontract, settlement agreement, lease, sublease, binding understanding, instrument, note, option, bond, mortgage, indenture, trust document, loan or credit agreement, license, sublicense, insurance policy or legally...
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Related to CNS Indication

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.